Methods for improving health in animals

ABSTRACT

A method of improving health in an animal includes administering to the animal a nutritional supplement comprising an amino acid secretagogue composition, which stimulates the pituitary gland in the animal to produce growth hormone. The nutritional supplement may be administered orally. The nutritional supplement may comprise L-arginine hydrochloride, L-pyroglutamic acid, L-lysine hydrochloride, and cysteine. When desired, the nutritional supplement may consist essentially of L-arginine hydrochloride, L-pyroglutamic acid, L-lysine hydrochloride, N-acetyl-L-cysteine, L-glutamine, and schizonepeta powder.

TECHNICAL FIELD

Embodiments of the present disclosure generally relate to methods andnutritional supplements for improving health in animals.

BACKGROUND

Growth hormone is an anabolic hormone capable of promoting lineargrowth, weight gain and whole body nitrogen retention in animals. Growthhormone is produced in somatotroph cells of the anterior pituitary glandof animals and secreted throughout life. It is mainly controlled in thebrain by two hypothalamic peptides: growth hormone releasing hormone(GHRH), which stimulates its secretion and synthesis; and somatostatin,which inhibits them. Growth hormone is known to promote skeletal growth,to increase nitrogen retention and protein synthesis, and to affectglucose and lipid metabolism in animals.

As animal grows older, the growth hormone undergoes considerabledecrement resulting in a loss of skeletal muscle mass, osteoporosis,increased fat deposition and decreased lean body mass. It has beendemonstrated that the development of these changes can be offset byrecombinant growth hormone therapy. However, current recombinant growthhormone therapy has several shortcomings including frequent subcutaneousor intravenous injections, insulin resistance and impaired glucosetolerance.

Growth hormone has been administered to animals to offset the growthhormone deficiency in aged animals. Furthermore, there are reports ofusing growth hormone to boost certain desirable performances of animals.For example, growth hormone has been used to enhance growth performancein animals by increasing lean body mass with an overall improvement infeed efficiency, and to enhance fertility in animals. Additionally,growth hormone has been used to stimulate milk production and achieve anenhanced milk yield in mammals.

U.S. Pat. No. 4,521,409, issued on Jun. 4, 1985 to Bauman, and U.S. Pat.No. 5,004,728, issued on Apr. 2, 1991 to Chalupa disclose theadministration of growth hormone to cattle and ruminants to stimulatemilk production with an increase in feed to milk conversion. In U.S.Pat. No. 5,416,073, issued on May 16, 1995 to Coy, growth hormone isused to increase milk production in dairy cows and to increase growthrates in animals such as cattle, sheep, and swine.

U.S. Pat. No. 5,008,244, issued on Apr. 16, 1991 to Miller discloses anadministration of growth hormone to food-producing animals to increasetheir fertility by improving embryonic survival and litter size duringthe reproductive stage of growth. In U.S. Pat. No. 5,583,106, issued onDec. 10, 1996 to Stanisiewski, an enhanced reproductive performance incattle is achieved by commencing administration of growth hormone duringthe early postpartum period.

U.S. Pat. No. 5,637,566, issued on Jun. 10, 1997 to Walker et al.describes the use of growth hormone to improve carcass quality and/orfood conversion efficiency in animals. In U.S. Pat. No. 4,792,546,issued on Dec. 20, 1988 to Baker, growth hormone is administered tofood-producing animals to increase weight gain and at the same timereduce fat deposition and improve the lean meat to fat ratio.

SUMMARY OF THE DISCLOSURE

The present disclosure includes a nutritional supplement and a method ofusing the same for improving health in animals. The nutritionalsupplement is an amino acid secretagogue composition, which stimulatesthe pituitary gland of animals to release growth hormone.

A particular embodiment of the present disclosure relates to anutritional supplement for improving health in animals, the nutritionalsupplement comprising L-arginine, L-pyroglutamic acid, L-lysine, andcysteine.

Another particular embodiment relates to a nutritional supplement forimproving health in animals, the nutritional supplement consistingessentially of L-arginine hydrochloride, L-pyroglutamic acid, L-lysinehydrochloride, N-acetyl-L-cysteine, L-glutamine and schizonepeta powder.

Other embodiments are drawn to methods of increasing growth hormone inanimals, the methods including administering the disclosed nutritionalsupplement to an animal. In particular embodiments, the method includesorally administering the disclosed nutritional supplement to an animal.

DETAILED DESCRIPTION OF THE DISCLOSURE

The present disclosure relates to methods and nutritional supplementsfor improving health in animals. The nutritional supplement is an aminoacid secretagogue composition, which stimulates the pituitary gland inan animal to produce growth hormone. Increased production of growthhormone in animals may prevent the loss of skeletal muscle mass,osteoporosis, increased fat deposition, decreased lean body mass, andother disorders. The supplement of the present disclosure may work as adietary supplement by assisting the animal's ability to secrete growthhormone naturally in a manner which is safe and effective.

As used herein, the term “animal” means any species of the kingdomAnimalia, including mammals, avians, reptiles or amphibians. It mayinclude a food-producing animal (e.g., chicken, turkeys, ducks, geese,guinea henspig, cattle, lambs, fish, etc.); a pet such as dog and cat;or a working animal such as horse.

As used herein, the term “mammal” means a warm blooded vertebrate,including non-human animals such as murine, porcine, canine and feline.It may include ungulates or hooved animals (e.g., cattle, goats, pigs,horse, sheep, etc.); rodents (e.g., guinea pigs, hamsters, mice, rats,etc.); lagomorphs such as rabbits; primates (e.g., monkeys, baboons,humans, etc.); or the like. By way of non-limiting examples, mammal mayinclude cattle, sheep, goat, or swine.'

A particular embodiment of the present disclosure relates to anutritional supplement for improving health of animals, the nutritionalsupplement including L-lysine, L-arginine, oxo-proline, and at least oneof cysteine and glutamine. The supplement may additionally include bothcysteine and glutamine and/or schizonepeta powder. In particularembodiments, a functional dosage may include L-arginine at a levelbetween 0.1-6 mmol, oxo-proline at a level between 0.1-8 mmol, and/orthe L-lysine in an amount between 0.1-12 mmol. The cysteine and/orglutamine may be contained at a level between 0.001-6 mmol. The cysteinemay be n-acetyl L-cysteine, and the glutamine may be L-glutamine. Theamino acids may be delivered as non-toxic salts thereof, effectivecomplexes thereof, stable chelates thereof, active esters thereof,functional derivatives thereof, or mixtures thereof, which are effectiveto increase growth hormone levels in animals. The nutritional supplementmay be present in an amount of 2.9 grams. Dosages are generallycalculated in the range of about 20-50 gms per kg of body weight of theanimal. The nutritional supplement may be administered to animalsorally. The supplement may be in any acceptable and known oralformulation including, but are not limited to, powder, tablet, capsule,or liquid form.

Another particular embodiment relates to a nutritional supplement forimproving health of animals, the nutritional supplement consistingessentially of L-lysine HCl, L-arginine HCl, oxo-proline, N-acetylL-cysteine, L-glutamine, and schizonepeta (aerial parts) powder. Inparticular embodiments, a functional dosage may include L-arginine HClat a level between 0.1-6 mmol, and oxo-proline at a level between 0.1-8mmol, and/or the L-lysine HCl in an amount between 0.1-12 mmol. Then-acetyl L-cysteine and/or L-glutamine may be contained at a levelbetween 0.001-6 mmol. In another particular embodiment, a functionaldosage may include L-arginine HCl at a level between 2.5-4.5 mmol,oxo-proline between 4-6 mmol, and/or the L-lysine HCl in an amountbetween 7-9 mmol. The n-acetyl L-cysteine and/or L-glutamine may becontained at a level between 0.001-0.5 mmol. The nutritional supplementmay be administered to animals orally. The supplement may be in anyacceptable and known oral formulation including, but are not limited to,powder, tablet, capsule, or liquid form.

Other embodiments are drawn to methods of increasing growth hormone inanimals, the methods including administering the disclosed nutritionalsupplement to an animal. In particular embodiments, the method includesorally administering the disclosed nutritional supplement to an animal.The amount of dosage and frequency of administration may be variedaccording to many factors including, but are not limited to, animalspecies, ages and health.

The disclosed nutritional supplements may be administered to an animalto improve health, including by: increasing growth performance;enhancing lean body mass with an overall improvement in feed efficiency;improving reproductively performance; stimulating milk production;boosting milk yield; or combinations thereof.

In accordance with the “consist essentially of” and “consistingessentially of” language, the nutritional supplement is essentiallylimited to the aforementioned ingredients and does not include anyadditional active ingredients intended to add nutritional content (e.g.,vitamins, minerals, etc.), but may include additional ingredients notintended to add nutritional content such as ingredients intended tofulfill a non-nutritional purpose (e.g., coloring, fillers, flavoring,an ingredient for maintaining the structural form, etc.).

Each ingredient of the nutritional supplement may be prepared inaccordance with any method known to one of ordinary skill in the art.Alternatively, each ingredient may be obtained in a fully prepared froma commercially available source.

The nutritional supplement may be in any suitable oral administrationform, including but not limited to: a chewable form, a liquid form, aspray form, a capsule form, a suppository form, dissolvable wafer, and apowder form.

Irrespective of the structural form of the nutritional supplement, theingredients of the nutritional supplement may be distributedhomogeneously or non-homogeneously within the nutritional supplement.

The nutritional supplement may be administered to an animal on a regularbasis, such as a weekly or monthly intake at a dosage tailored to theanimal's needs; i.e., the nutritional supplement may be administeredregularly as multiples (1×, 2×, etc.) of the structural units (pills,tablets, capsules, etc.) in accordance with the needs of the animal. Forexample, an elderly animal is likely to need higher daily doses thandoes a young animal. Alternatively, the nutritional supplement may beadministered on an as-needed basis at a dosage tailored to the animal'sneeds, such as administering the nutritional supplement to cattle duringthe early postpartum period to enhance reproductively performance.Veterinarian counseling may be beneficial for arriving at a desirable oroptimal dosage tailored to the animal's needs.

The combination of types of amino acids, mass ranges, and specificformulations may be selected to be synergistically balanced and ofadequate quantity to achieve the desired physiological effect, namely,growth hormone release. Improper combinations of the amino acids may beineffective. The component amino acids are synergistic in the sense thatseveral of them when combined together, synergistically stimulate therelease of human growth hormone. The combination may also be chosen toreduce or inhibit chemical combination or reaction between the aminoacids.

EXAMPLES Example 1

The short-term effects of the disclosed supplement on the growth hormonelevel in animals are tested two hours after administration. The animalsubjects are administered the capsules of supplement (SeroVital™) or anidentical looking placebo. SeroVital™ is a blend of l-lysine HCl,l-arginine HCL, oxo-proline, N-acetyl-1-cysteine, l-glutamine, andschizonepeta (aerial parts) powder. Animal subjects are administeredapproximately 35 gms per kg of body weight. Blood is drawn at 15, 30, 60and 90 and 120 minutes for assay. The growth hormone level is measuredat each time point using the Siemens Immulite 2000 (intra-assay CV was3.72%, inter-assay CV was 5.70%, and the detection limit for GH was0.05ng/ml). The 15 and 120 minute time points are additionally assayedfor triiodothyronine (T3) as informative for mechanistic investigations.

The mean growth hormone in the animal subjects are increased more than600% after the administration of supplement from 0.17 at baseline to1.33ng/ml at 120 minutes, while there is are no increases observed inthe mean growth hormone of the animal subjects after the administrationof placebo.

The growth hormone levels from baseline to 120 minutes (the growthhormone level at 120 minutes minus the growth hormone level at 0minute), are increased about two fold when compared to theadministration of a placebo. Overall, 120 minutes after theadministration of the supplement, the growth hormone levels aresignificantly higher in absolute levels or by AUC.

Furthermore, the animals that were administered SeroVital™ will exhibita deceased reduction in T3 by nearly one-half over the same time period,compared to the animals administered with the placebo. These resultsaffirm that somatostatin inhibition plays a mechanistic role in theability of SeroVital™ to induce significant increases in serum growthhormone levels in animal subjects.

These findings demonstrate that a specialized low-dose amino acidsupplement can significantly increase short-term growth hormone levelsin animals.

Example 2

The effect of the nutritional supplement on endurance and fat metabolismin animals are investigated. Each animal subject is measured forbaseline weight, height, body fat percent and resting metabolic rate.Then, each animal subject is administered with the supplementSeroVital™, which is a blend of l-lysine HCl, l-arginine HCl,oxo-proline, N-acetyl-1-cysteine, l-glutamine, and schizonepeta (aerialparts) powder for 2 weeks before being measured again for weight,height, body fat percent and resting metabolic rate. The measurementsbefore and after the administration of the supplement are analyzed.

Mean VO_(2max) of the animal subjects increases compared to baseline.After the period of supplementation with SeroVital™, the mean RMRincreases compared to baseline (P=0.165). Estimated daily calorieexpenditure also increases.

After two weeks of supplementation with the supplement SeroVital™, bothRMR and estimated daily calorie expenditure of the animal subjects tendto increase, evidencing the potential of the supplement to impartlong-term fat burning effects. Additionally, endurance as measured byVO_(2max) in the post-absorptive state significantly improves. Overall,the animal subjects administered with the SeroVital™ supplement willshow enhanced parameters of endurance, energy, and vitality.

Example 3

The effect of the nutritional supplement on lean body mass and weightchange of animals is studied. The animal subjects in the first group aregiven daily doses of the nutritional supplement for 6 months atdifferent dosing concentrations of active ingredients, while the animalsubjects in the second group are given placebo. Weight, percent leanbody mass, and percent fat body mass are chosen as primary measures ofbody composition at the 6 month analysis period. The weight, bodycomposition, and physical performance (including endurance) of theanimal subjects are determined before and after the treatment, alongwith hormonal data analysis.

The animal subjects treated with the nutritional supplement show asustained increase in lean body mass and an improved physicalperformance.

While embodiments of the present invention have been described hereinfor purposes of illustration, many modifications and changes will becomeapparent to those skilled in the art. Accordingly, the appended claimsare intended to encompass all such modifications and changes as fallwithin the true spirit and scope of this invention.

1. A method of increasing human growth hormone in a mammal, comprising:providing a nutritional supplement, comprising: about 1 mmol L-arginine;about 1 mmol Oxo-proline; about 2 mmol L-lysine; about 1.5 μmol N-acetylL-cysteine; about 2 μmol L-glutamine; and about 125 μg Schizonepta(aerial parts) powder; administering the nutritional supplement to theanimal.
 2. (canceled)
 3. (canceled)
 4. (canceled)
 5. (canceled)
 6. Themethod of claim 1, wherein administering the nutritional supplementcomprises orally administering.
 7. The method of claim 1, whereinadministering the nutritional supplement comprises administering about20-50 gms/kg of body weight of the nutritional supplement.
 8. The methodof claim 1, wherein the nutritional supplement is in powder, tablet,capsule, liquid, or wafer form.
 9. The method of claim 1, wherein thenutritional supplement is administered once a week or once a month. 10.The method of claim 1, wherein the nutritional supplement isadministered for at least one of following in the animal: increasinggrowth performance, enhancing lean body mass, improving reproductivelyperformance, stimulating milk production, boosting milk yield, andincreasing a feed efficiency.
 11. A method of increasing human growthhormone in a mammal, comprising: providing a nutritional supplement,comprising: 3.44 mmol L-arginine; 5.30 mmol Oxo-proline; 8.21 mmolL-lysine; 6.13 μmol N-acetyl L-cysteine; 6.84 μmol L-glutamine; and 0.50mg Schizonepta (aerial parts) powder; and administering the nutritionalsupplement to the animal.
 12. The method of claim 11, wherein thenutritional supplement consists of 725.50 mg L-arginine HCl; 683.70 mgL-pyroglutamic acid; 1499.30 mg L-lysine HCl; 1.00 mg N-acetylL-cysteine USP; 1.00 mg L-glutamine; and 0.50 mg Schizonepta (aerialparts) powder.
 13. The method of claim 11, wherein amino acids of thenutritional supplement composition may be dlivered as non-toxic saltsthereof, effective complexes thereof, stable chelates thereof, activeesters thereof, functional derivatives thereof, and mixtures thereof.14. The method of claim 11, wherein administering the nutritionalsupplement comprises orally administering the nutritional supplement.15. The method of claim 11, wherein administering the nutritionalsupplement comprises administering about 20-50 gms/kg of body weight ofthe nutritional supplement.
 16. The method of claim 11, wherein thenutritional supplement is in powder, tablet, capsule, liquid, or waferform.
 17. The method of claim 11, wherein the nutritional supplement isadministered once a week or once a month.
 18. The method of claim 11,wherein the nutritional is administered one to three times daily. 19.The method of claim 11, wherein the nutritional supplement isadministered on an empty stomach.
 20. The method of claim 11, whereinthe nutritional supplement is administered for at least one of followingin the animal: increasing growth performance, enhancing lean body mass,improving reproductively performance, stimulating milk production,boosting milk yield, and increasing a feed efficiency.